U.S. patent application number 16/893737 was filed with the patent office on 2020-11-19 for push-pull medication container adapter cap for enteral syringe filling systems.
The applicant listed for this patent is Nicholas J Perazzo, Robert A Rosen. Invention is credited to Nicholas J Perazzo, Robert A Rosen.
Application Number | 20200360608 16/893737 |
Document ID | / |
Family ID | 1000005004436 |
Filed Date | 2020-11-19 |
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United States Patent
Application |
20200360608 |
Kind Code |
A1 |
Perazzo; Nicholas J ; et
al. |
November 19, 2020 |
PUSH-PULL MEDICATION CONTAINER ADAPTER CAP FOR ENTERAL SYRINGE
FILLING SYSTEMS
Abstract
A medication container adapter that utilizes a push-pull valve
for adapting medication containers for use with syringes that are
filled on semi-automatic and automatic filling machinery. The
syringes are filled when the medication container is in the
inverted filling position. The push-pull valve comprises of a
stationary portion and a poppet slidably inserted into the
stationary portion. The poppet is an annular member having a
central channel and a fluted axial outlet from the central channel.
The push-pull valve can be configured to be pressed onto an
existing medication container adapter or manufactured as an
integrated part of the medication container adapter so that it can
either be screwed onto or pressed into the medication container
neck.
Inventors: |
Perazzo; Nicholas J;
(Rosedale, MD) ; Rosen; Robert A; (Owings Mills,
MD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Perazzo; Nicholas J
Rosen; Robert A |
Rosedale
Owings Mills |
MD
MD |
US
US |
|
|
Family ID: |
1000005004436 |
Appl. No.: |
16/893737 |
Filed: |
June 5, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15274702 |
Sep 23, 2016 |
|
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16893737 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B65B 3/003 20130101;
A61M 39/20 20130101; B65B 5/045 20130101; B65B 57/02 20130101; B65B
7/28 20130101; A61J 7/0053 20130101; B65B 3/30 20130101; A61M
2039/2486 20130101; A61M 39/24 20130101; G16H 20/17 20180101; B65B
3/28 20130101; A61M 5/1782 20130101 |
International
Class: |
A61M 5/178 20060101
A61M005/178; A61M 39/24 20060101 A61M039/24; A61M 39/20 20060101
A61M039/20; B65B 7/28 20060101 B65B007/28; B65B 5/04 20060101
B65B005/04; B65B 3/28 20060101 B65B003/28; B65B 3/30 20060101
B65B003/30; B65B 3/00 20060101 B65B003/00; B65B 57/02 20060101
B65B057/02; G16H 20/17 20060101 G16H020/17 |
Claims
1. A method of filling of a syringe with medication, comprising the
steps of: loading a container of medicine into a loading station of
a filling system, said medication container comprising a closure
having a push-pull nozzle; inverting the medication container;
loading a syringe to fill with medicine from said container into
said loading station of said filling system; inserting said syringe
into said push-pull nozzle of the medication container; opening
said push-pull nozzle of said the medication container closure;
withdrawing a plunger of said syringe to thereby fill said syringe
with medicine from said medicine container; closing said push-pull
nozzle; and withdrawing the syringe from the medication
container.
2. The method of claim 1, wherein said syringe is any one from
among the group of an enteral syringe, an oral syringe.
3. The method of claim 1, wherein said step of opening said
push-pull nozzle comprises slidably withdrawing said push-pull
nozzle.
4. The method of claim 1, further comprising a step of installing
said closure onto said medicine container by screw-attachment.
5. The method of claim 1, further comprising a step of installing
said closure onto said medicine container by press-fit
insertion.
6. The method of claim 1, wherein said step of inverting the
medication container comprises gripping said adapter cap by a first
flange protruding laterally from and encircling said annular
member.
7. The method of claim 3, wherein said step of opening said
push-pull nozzle comprises gripping a flange protruding laterally
from and encircling said annular member.
8. The method of claim 1, wherein said step of attaching a syringe
comprises inserting said syringe into an inwardly tapered radial
inlet of said annular member.
9. A method for preparing medication containers for automated
filling of syringes, comprising the steps of, receiving a plurality
of medication containers, filling said plurality of medication
containers with medicine from a singular batch having a known batch
lot code; entering said batch lot code into a database; installing
a cap on each of said plurality of medication containers, said caps
all comprising a syringe filling interface for automated filling of
a syringe; assigning a unique identifier to each of said plurality
of medication containers; entering said unique identifier into said
database in association with said batch lot code, printing a
plurality of labels all indicating said known batch lot code and a
unique identifier; and placing the plurality of labels on the
plurality of medication containers.
10. The method of claim 9, further comprising a step of scanning
each of said plurality of labels and verifying that the contents
are correct.
11. A method for filling syringes with medication from a medication
container, comprising the steps of: attaching an adapter cap to a
medication container, said adapter cap having a stationary portion
comprising an annular base and neck having a central channel, and a
poppet slidably inserted into the neck; inverting the medication
container; inserting said syringe into said adapter cap; opening
said poppet; and withdrawing a plunger of said syringe to thereby
fill said syringe with medicine from said medicine container.
12. The method of claim 11, further comprising a step of closing
said push-pull nozzle.
13. The method of claim 12, further comprising a step of
withdrawing the syringe from the medication container.
14. The method of claim 11, wherein said syringe is any one from
among the group of an enteral syringe, and an oral syringe. =.
15. The method of claim 11, wherein said step of inverting the
medication container comprises gripping said adapter cap by a
flange.
16. The method of claim 14, wherein said step of opening said
poppet comprises gripping said poppet by a flange.
17. The method of claim 10, wherein said step of attaching a
syringe comprises inserting said syringe into an inwardly tapered
radial inlet of said adapter cap.
18. A method of filling of a syringe with medication from a
medicine container comprising the steps of: providing a medicine
container having a closure with a push-pull valve; inverting the
medication container; attaching a syringe for filling the syringe
with medication from said medicine container; opening said closure
push-pull valve; withdrawing a plunger of said syringe to thereby
fill said syringe with medicine from said medicine container;
closing said closure push-pull valve; and withdrawing the syringe
from the medication container.
19. The method of claim 18, wherein said step of opening said
push-pull valve comprises slidably withdrawing said push-pull
valve.
20. The method of claim 18, wherein said step of providing a
medicine container comprises installing an adapter cap on said
medicine container.
21. The method of claim 18, wherein said step of opening said
push-pull valve comprises gripping said push-pull valve by at least
one projecting flange.
22. The method of claim 18, wherein said step of attaching a
syringe comprises inserting said syringe into an inwardly tapered
radial inlet of said closure.
23. The method of claim 18, wherein said step of inverting the
medication container comprises gripping said closure by a first
projecting flange protruding laterally from and encircling said
closure.
24. The method of claim 23, wherein said step of opening said
poppet comprises gripping said poppet by a second projecting flange
protruding laterally from and encircling said poppet.
25. A method of filling a syringe with medication, comprising
loading a container of medicine into a filling system, loading a
syringe to fill with medicine from said container into said filling
system, inserting said syringe into a closure of said medication
container, opening a valve of said medicine container, withdrawing
a plunger of said syringe to thereby fill said syringe with
medicine from said medicine container, and withdrawing the syringe
from the medication container.
26. The method of claim 25, wherein said syringe is any one from
among the group of an enteral syringe, an oral syringe.
27. The method of claim 25, wherein said valve is a push-pull
valve.
28. The method of claim 27, wherein said step of opening a valve of
said medicine container comprises gripping said valve by flange
protruding laterally therefrom.
29. The method of claim 25, wherein said step of inserting said
syringe comprises inserting said syringe into an inwardly tapered
radial inlet of said closure.
30. A method for manufacturing medicine containers for use in
automated filling of syringes with medicines from said containers,
said syringes being of various sizes and types all having a barrel,
an annular flange encircling said barrel, a plunger slideably
engaged in said barrel, and a flange at distal end of said plunger,
the method comprising the steps of: assigning a batch code to a
batch of prescription medicine; storing said batch code in a
database; filling a medicine container with prescription medicine
from said batch; installing a cap on said filled medicine
container, said cap having a leak-proof valve for insertion of a
syringe; assigning a unique identification code to said filled and
capped medicine container; storing said unique identification code
in a database in association with said batch code; and attaching an
indicia to said medicine container identifying said batch code and
unique identification code.
31. The method for manufacturing medicine containers according to
claim 30, wherein said indicia comprises a 2D barcode.
32. The method for manufacturing medicine containers according to
claim 30, wherein said indicia comprises an RFID tag.
33. The method for manufacturing medicine containers according to
claim 30, wherein said valve comprises a push-pull valve.
34. The method for manufacturing medicine containers according to
claim 30, wherein said valve comprises a duck bill valve.
35. The method for manufacturing medicine containers according to
claim 30, further comprising a step of storing supplemental
information in said database comprising any one or more of a batch
expiry date, storage instructions, National Drug Code, whether to
shake before use, whether to refrigerate, whether to protect from
light, and volume of medication container.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a division of U.S. application
Ser. No. 15/274,702 filed 2016 Sep. 23.
BACKGROUND OF THE INVENTION
1. Field of the invention
[0002] The present invention relates generally to enteral syringe
packaging equipment and more specifically to an adapter cap
incorporating a push-pull valve optimized for use in a fully or
partially automated system for preparing patient-specific doses of
selected pharmaceutical liquid medication for administration by
syringe.
2. Description of the Background
[0003] Oral syringes are used to dispense liquids into the mouth.
Enteral syringes are used to dispense liquids into the
gastro-intestinal tract through a tube. As shown in FIG. 1, oral
syringes utilize a male tapered tip. Enteral syringes utilize a
luer-lock tip as shown in FIGS. 2A & 2B. Both types of syringes
are typically filled with medication on-demand at hospital
pharmacies, from bulk medication containers supplied by OEM
manufacturers. The hospitals and pharmacies maintain health records
identifying the prescribed patient, prescribing physician, and
prescription dosages and schedule. The OEM medication manufacturers
also maintain important records for each bulk container including
batch number, expiry date, storage instructions, product name,
strength, name of the active ingredient(s), dose form, warning
statements, National Drug Code (NDC), requirements to be shaken,
refrigerated, protected from light, recalls, etc. However, hospital
health records lack the OEM information and vice versa. Thus,
hospital pharmacists seeking to fill oral and enteral syringes with
medication on-demand at hospital pharmacies from bulk medication
containers supplied by OEM manufacturers often lose considerable
time contacting the OEM manufacturer for this information. The
problem becomes even more apparent as the filling process becomes
more automated. What is needed is a smart-container for bulk
medicine that carries the OEM information with it.
[0004] Hospital pharmacists prefer to fill just one type of syringe
because they typically do not know whether a prescription will
ultimately be administered orally or enterally. Another issue of
great concern relates to mistaken use of syringes. Syringes
intended to be dispensed into the mouth or into an enteral tube
can, inadvertently, though rarely, be dispensed into an intravenous
(IV) patient port. Such mistakes have caused injury and death to
patients. Both of these problems have recently been addressed by
the Global Device Suppliers Association (GEDSA). This industry
group has introduced new devices referred to as ENFIT.TM. which
include enteral syringes. The ENFIT.TM. devices are not compatible
with luer connections or any other type of small bore medical
connectors. This ENFIT.TM. design prevents the misconnection of
enteral syringes to the patient's tubing port. As a result of the
GED5A organizations efforts, the International Standards
Organization created ISO CD 803069-3 which specifies the safe
design for an enteral feeding connection. The new ENFIT.TM. enteral
syringes comply with ISO CD 80369-3, can be used to administer
medication orally or enterally, and cannot easily be connected to
an incorrect patient tubing port.
[0005] As shown in FIG. 1, oral syringes have a tapered tip which
can be used with a medication container to syringe adapter with an
elastomer valve for filling the syringe when the container is in
the inverted position.
[0006] The tapered tip of the oral syringe (See FIG. 1) penetrates
the elastomer valve which enables the syringe to extract the liquid
from the medication container. This adapter arrangement is not
suitable for filling enteral syringes as the enteral syringe has a
female fitting on the tip and is not compatible with the elastomer
valve adapter used for the oral syringe.
[0007] To address this problem, a new Push-Pull Valve Adapter (for
which this patent application is based) was developed by the
Inventors specifically for use with the female luer tip of the
enteral syringe (refer to FIGS. 5 & 6).
[0008] Prior to filling the syringe, the valve is closed (FIG. 5).
During the filling of the syringe, a mechanical actuator FIG. 5
(valve opener/closer), located at the fill station, opens the valve
FIG. 6. When the syringe has been filled, the same mechanical
actuator closes the valve.
[0009] The initial design of the enteral syringe tip caused excess
liquid to accumulate in the tip of the syringe which caused
unacceptable fill accuracy for the smaller size enteral syringes. A
new design which incorporates an inner nozzle within the syringe
discharge port addressed this problem (FIG. 5).
[0010] The change in the design of the discharge port of the
enteral syringe required a new design for the syringe to medication
adapter valve. This design changes obviated the prior art. A new
adapter needed to fill both the smaller enteral syringes that had
the center nozzle port (FIG. 5) as well as the larger syringes
which did not have the center nozzle port (FIG. 11) without using
change parts.
[0011] Thus, as shown in FIG. 2, two versions of enteral syringes
now exist. As shown in FIG. 2(A) larger enteral syringes (typically
5 cc and above) utilize an internally-threaded female luer-lock tip
and no center nozzle. As shown in FIG. 2(B) smaller enteral
syringes (typically 0.5 ml-3 ml) utilize an internal tapered or
slip-nozzle with an enteral threaded female luer-lock and a center
nozzle.
[0012] Automated filling systems have been developed by Baxa, Inc.,
For Health Technologies, Inc., Intelligent Hospital Systems,
Applicant National Instruments Co. (see, for example, Applicant's
U.S. Ser. No. 13/788,849 filed Mar. 7, 2013 and others for the
automated filling of syringes). However, the degree of automation
in the hospital pharmacy for the packaging of oral/enteral syringes
is limited due to the wide array of different syringes to fill, the
different medicine containers to fill them from, and the lack of
OEM information on bulk medication containers supplied by OEM
manufacturers. Bulk medications are commonly provided in variously
sized bottles or containers having threaded screw caps that must be
removed and replaced with container-to-syringe adapter caps. Most
any attempt at automated filling of any syringes requires a
modification to standard manufacturer-supplied medicine containers.
Semi-automated and automated filling of syringes requires that the
medication container be in the inverted position while the syringe
is being filled. It is also necessary that the medication container
cap be open during the time that the syringe is being filled, and
closed when the syringe has been filled to prevent leakage. Thus,
the manufacturer-supplied screw-on caps must be removed and
replaced by an adapter cap that allows the syringe to be connected
to the medication container. To fill oral syringes it is known to
use an adapter cap with an elastomeric valve that allow the syringe
tip (FIG. 1) to penetrate the inverted container. The tapered tip
of the oral syringe would penetrate the elastomer valve while the
medicine container is held in an inverted position, enabling the
syringe to extract the liquid from the medication container without
leakage.
[0013] Unfortunately, the elastomeric seal-type adapter cap does
not work with enteral syringes which are manufactured in a variety
of sizes with differing plunger configurations (FIGS. 2A, 2B). The
prior art adapter arrangement is not suitable for filling enteral
syringes (FIGS. 2A, 2B) since the enteral syringe has a female
fitting on the tip and is not compatible with the elastomer valve
adapter used for the oral syringe.
[0014] Given the diversity of enteral syringes and medicines
available, any semi-automated (or fully-automated) system will need
sufficient dexterity to manipulate all the myriad prescription
bottles containing the pharmaceuticals to be dispensed as well as
variously sized enteral syringes, bringing them together in a
controlled environment to quickly and accurately fill and label
each syringe and to verify its work as it proceeds in order to
avoid errors in the process. Existing adapter caps are incapable of
use with enteral syringes that are being filled on an automated or
semi-automated basis when the medication container is in the
inverted position. Consequently, existing adapter caps do not
address the needs of medical institutions desiring a semi-automatic
or automatic enteral syringe filling system when the medication
container is in the inverted position. In addition, an improved OEM
bulk container is needed that includes batch number, expiry date,
storage instructions, product name, strength, name of the active
ingredient(s), dose form, warning statements, National Drug Code
(NDC), requirements to be shaken, refrigerated, protected from
light, recalls, etc., e.g., a smart-container that carries the
foregoing OEM information with it. The present invention was
developed to fill these voids.
SUMMARY OF THE INVENTION
[0015] To address the need to fill enteral syringes, on a
semi-automatic or automated basis, with the medicine container held
in the inverted filling position, a push-pull adapter cap is herein
disclosed. When filling the syringe the valve is open. After the
syringe has been filled the valve is closed. The push-pull valve is
open or closed by a mechanical actuator at the automated or
semi-automated filling station.
[0016] The push-pull adapter cap disclosed herein, when used with
an enteral syringe filling system, enables hospital pharmacists to
simplify and streamline their task, increasing the number of
prescriptions that can be filled in a day, and improving patient
safety and care by minimizing medication errors and the
consequences that ensue.
[0017] In addition, a smart-container for bulk medicine that
carries OEM information with it is provided, including batch
number, expiry date, storage instructions, product name, strength,
name of the active ingredient(s), dose form, warning statements,
National Drug Code (NDC), requirements to be shaken, refrigerated,
protected from light, recalls, etc. This way, hospital pharmacists
seeking to fill oral and enteral syringes with medication on-demand
at hospital pharmacies from bulk medication containers supplied by
OEM manufacturers have the OEM information at their disposal when
filling the syringes, saving considerable time, effort and
cost.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The objects, features, and advantages of the present
invention will become apparent from the following detailed
description of the preferred embodiments and certain modifications
thereof when taken together with the accompanying drawings in which
like numbers represent like items throughout and in which:
[0019] FIG. 1 is a perspective view of a conventional oral syringes
with tapered tip.
[0020] FIG. 2(A) is a perspective view of a large-sized
conventional enteral syringe with internally-threaded luer-lock
tip.
[0021] FIG. 2(B) is a perspective view of a smaller-sized
conventional enteral syringe with an internal tapered or
slip-nozzle and an enteral threaded female luer-lock.
[0022] FIG. 3 is a perspective exploded view of a push-pull adapter
cap 10 for retrofit application to a standard manufacturer-supplied
medication container cap such as a Baxa.TM. or equivalent
valve-less medicine container adapter cap with opening.
[0023] FIG. 4 is a perspective view of the push-pull adapter cap 10
of FIG. 3 illustrating how it interfaces an automated filling
system.
[0024] FIGS. 5-6 are sequential perspective views of the push-pull
adapter cap 10 of FIGS. 3-4 illustrating how it interfaces a
smaller-sized enteral syringe (with internal tapered slip-nozzle
and enteral threaded female luer-lock) while in the automated
filling system.
[0025] FIG. 7 is a side view of the poppet 84 used in the push-pull
adapter cap 10 of FIGS. 3-6.
[0026] FIG. 8 is an end cross-section of the poppet valve of FIG.
7.
[0027] FIG. 9 is a side cross-section of the press-on ring 60 used
for attaching the push-pull adapter cap 10 of FIGS. 3-8 to a
standard manufacturer-supplied medication container adapter
cap.
[0028] FIG. 10 is a side cross-section of a modified press-in
version used for attaching the push-pull adapter cap 10 inside the
neck of a standard manufacturer-supplied medication container
cap.
[0029] FIGS. 11-12 are sequential perspective views of the
push-pull adapter cap 10 of FIGS. 3-6 illustrating how it
interfaces a larger-size enteral syringe lacking a center nozzle,
thereby illustrating the device's ability to adapt to both small
syringes (with nozzle) and large syringes (w/o center nozzle).
[0030] FIG. 13 is a cross-section of the poppet valve of the
present invention inserted into a large enteral syringe and
illustrating the poppet valve circumferential seal surfaces on the
large enteral syringe in accordance with the invention. FIG. 14 is
a cross-section of the poppet valve of the present invention
inserted into a small enteral syringe and illustrating the poppet
valve circumferential seal surfaces on the small enteral syringe in
accordance with the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
exemplary embodiment illustrated in the drawings and described
below. The embodiment disclosed is not intended to be exhaustive or
limit the invention to the precise form disclosed in the following
detailed description. Rather, the embodiment is chosen and
described so that others skilled in the art may utilize its
teachings. It will be understood that no limitation of the scope of
the invention is thereby intended. The invention includes any
alterations and modifications in the illustrated device, the
methods of operation, and further applications of the principles of
the invention which would normally occur to one skilled in the art
to which the invention relates.
[0032] FIG. 3 is a perspective exploded view of a push-pull adapter
cap 10 for retrofit application to a standard manufacturer-supplied
(Baxa.TM. or Baxa equivalent) medicine container cap or equivalent
valve-less medicine container cap with opening. For purposes of
definition, this pre-existing medicine container cap is herein
designated the "OEM cap." Adapter cap 10 generally comprises a
stationary portion 12 for attachment to the OEM cap, a poppet 84
slidably inserted into the stationary portion 12, a plurality of
0-rings inclusive of a fluid seal 94 and two poppet seals 92,
96.
[0033] Stationary portion 12 comprises an annular body with a
central passage 22 there through, the central passage 22 being
defined by an inner wall having a specific progression of diametric
variations. At one end of the body of stationary portion 12, where
stationary portion 12 attaches to the top of the
manufacturer-supplied medicine container cap, central passage 22
has a relatively large diameter sized to conform to and receive the
nozzle of the manufacturer-supplied medicine container cap as
described below with reference to FIG. 8. This forms a "press-fit"
seal. It will be understood by one of ordinary skill in the art,
however, that stationary portion 12 may be sized to fit other
manufacturer-supplied caps by different means based on design
preference, such as a screw-on connection.
[0034] Central passage 22 continues partially through stationary
portion 12 at a relatively constant diameter but then constricts at
a shoulder 98 to a smaller diameter sized to accommodate the
elastomer poppet 84, as will be described further herein, which
protrudes from the distal end of passage 22. The outer wall of
stationary portion 12 further comprise two spaced annular flanges
24 separated by an annular groove 26 for alignment with a
stationary yoke of the filling station, as further described
herein. Similarly, the outer wall of poppet 84 is equipped with two
spaced annular flanges 89 separated by an annular groove 88 for
alignment with a movable yoke of the filling station, as further
described herein.
[0035] FIG. 4 is a perspective view of the push-pull adapter cap 10
of FIG. 3 illustrating how it interfaces an automated filling
system. The automated filling system employs at least one anchoring
yoke and at least one poppet-manipulating yoke, although one
skilled in the art will recognize that counter-opposed pairs of
such yokes may be used. The anchoring yoke(s) fit within the
annular groove 26 of stationary portion 12 described above to
thereby securely hold the medicine container by its
manufacturer-supplied cap in a fixed position. The
poppet-manipulating yoke fits within the annular groove 88 of
poppet 84 described above to thereby insert and/or extract the
poppet 84 from the stationary portion 12, thereby closing or
opening the valve.
[0036] FIGS. 5-6 are sequential cross-sections of the push-pull
adapter cap 10 of FIGS. 3-4 illustrating how it interfaces an
enteral syringe while in the automated filling system. Note that
the syringe in FIGS. 5-6 is a smaller-size enteral syringe with
luer-lock enteral fitting and internal tapered slip-nozzle. In
adapter cap 10 the central passage 22 continues approximately
two-thirds through the stationary portion 12 at a relatively
constant diameter d1, to a point approximately even with the lower
flange 26. However, that constant diameter passage is interrupted
at about its midpoint by a shallow annular notch 97. Notch 97
provides for snap-fit capture of the OEM cap by its nozzle, which
as shown is typically provided with a distal flange for snap-fit of
a nozzle cap. The central passage 22 continues at constant diameter
d1 to a shoulder 98 where is constricts to a smaller diameter d2
sized to accommodate the elastomer poppet 84, as will be described
further herein, which protrudes from the distal end of passage 22.
Poppet 84 likewise has a central passage 85 leading from a radial
inlet 87 to an axial outlet 86. Note that the tip of poppet 84 is
externally-tapered yet the central passage 85 is cylindrical
leading to axial outlet 86. This way, the tip of poppet 84 exactly
fits the moat between the enteral syringe luer-lock enteral fitting
and internal tapered slip-nozzle, preventing any accumulation of
medicine and undesired leakage.
[0037] In operation, when the poppet 84 is fully extracted as seen
in FIG. 5 the inlet 87 is sealed within the smaller diameter d2
portion of passage 22 and forms a fluid-tight seal. Conversely,
when the poppet 84 is fully inserted as seen in FIG. 6 the inlet 87
pushes above shoulder 98 and is freed within the larger diameter d1
portion of passage 22. Medicine is free to flow through the poppet
84 as seen by the arrows of FIG. 6 for filling of a syringe
(below).
[0038] FIGS. 7 and 8 are a cross-section and side view of the
poppet 84, which is an annular member formed with a plurality of
grooves 101-105 spaced axially, and central passage 85 running
centrally and axially and leading from a radial inlet 87 to an
axial outlet 86. Radial inlet 87 may be any one or more
inlet-passages extending radially into poppet 84 and in fluid
communication with passage 85. Outlet 86 is enlarged and
inwardly-fluted to receive and conform to the tapered nozzles of
most enteral syringes. The grooves 101-105 include a lowermost
groove 101 for receiving the smaller articulating yoke of the
filling system which thereby inserts and/or extracts the poppet 84
from the stationary portion 12, thereby closing or opening the
valve. In addition, three grooves 102, 103 and 105 are provided for
three O-rings, inclusive of a groove 105 for a poppet seal 94 above
the inlet 87 for sealing the poppet 84 against the shoulder 98 when
fully open, and two lower grooves 103, 105 below the inlet 87 for
fluid seals 95, 96 thereby preventing leakage out around poppet
84.
[0039] FIG. 9 is a side cross-section of the press-on ring 60 used
for attaching the push-pull adapter cap 10 of FIGS. 3-6 to a
standard manufacturer-supplied medication container cap. It is
noteworthy that distal end of stationary portion 12 forms a nozzle
through which the smaller diameter d2 portion of passage 22 passes,
and the inner walls of this nozzle are formed with two spaced
grooves forming O-ring seats 101 as shown for seating the fluid
seals 95, 96 of poppet 84 when it is in its fully extracted
position, and thereby ensuring a fluid-tight closure.
[0040] At the distal end of stationary portion 12 the outer
diameter of the nozzle is sized to fit inside the female nozzle of
a Luer lock oral syringe. The fluted outlet 86 of poppet 84 is
configured to receive and conform to the tapered nozzles of most
enteral syringes. This particular confirmation is well-suited for
attachment to all variety of oral/enteral syringes inclusive of a
Luer lock syringe with or without nozzles.
[0041] One skilled in the art will understand that other
configurations may be used for attachment to other medicine
containers. For example, the inner wall of the adapter cap along d2
may be defined by a simple inwardly-threaded connection for
screw-insertion onto the threaded container neck. Alternately, the
inner wall of the adapter cap 10 along d2 may be formed with a
series of integrally formed inwardly-directed circular gripping
ribs for gripping the neck of a medicine container by its
threads.
[0042] FIG. 10 is a side cross-section of a modified press-in
version used for attaching the push-pull adapter cap 10 inside the
neck of a standard manufacturer-supplied medication container cap.
Rather than fitting around the medicine container neck the ring
fits inside, sealing by a plurality of resilient annular ribs 107
thereby ensuring a fluid-tight closure.
[0043] Alternatively, the ring may fit outside the medicine
container neck using a plurality of inwardly-directed resilient
annular ribs 107 to ensure a fluid-tight closure. In this case, as
the neck of a medicine container is forced into the central void,
the ribs 107 engage the threads on the outside of the neck of the
bottle and flex slightly to permit the threads to pass. Once past,
the ribs 107 spring back toward their original position and press
against the neck to engage the threads and secure the adapter cap
10 to the container. Whether male or female, the flexure of the
ribs 107 permits the adapter cap 10 to accommodate size variations
in outside neck diameter and thread finish, and create a
fluid-tight seal without the need for a specific thread pitch. The
foregoing is set forth in more detail in co-pending application
Ser. No. 13/788,849 filed Mar. 7, 2013, which is herein
incorporated by reference in its entirety.
[0044] FIGS. 11-12 are sequential perspective views of the
push-pull adapter cap 10 of FIGS. 3-9 illustrating how it
interfaces with both the larger-size enteral syringe lacking a
center nozzle, and the smaller size enteral syringe with center
nozzle thereby illustrating the device's ability to adapt to both
small syringes(with nozzle) and large syringes (w/o center nozzle).
As above, the tip of poppet 84 is externally-tapered and exactly
fits the orifice of the enteral syringe luer-lock enteral fitting
preventing any accumulation of medicine in the smaller enteral
syringe tip with center nozzle. Thus the tip of the poppet valve is
able to be used with both the small enteral syringe with center
nozzle and the larger enteral nozzle without the center nozzle.
[0045] FIG. 13 is a cross-section of the poppet valve 84 of the
present invention inserted into a large enteral syringe and
illustrating the poppet valve circumferential seal surfaces on the
large enteral syringe lacking a center nozzle. As above, the tip of
poppet 84 is externally-tapered, i.e., has a tapered outer diameter
that exactly mates ("taper-locks") with the outermost internal
surface of the large enteral syringe luer lock to create a first
circumferential seal 112.
[0046] FIG. 14 is a cross-section of the poppet valve 84 of the
present invention inserted into a small enteral syringe and
illustrating the poppet valve circumferential seal surfaces on the
small enteral syringe with internal center nozzle. The poppet valve
84 is configured as above for the first circumferential seal 112
plus the poppet central channel has a tapered outlet configured to
mate with the outermost external surface of the enteral syringe
nozzle to create a second circumferential seal 114. For the smaller
enteral syringes these two seals "taper-lock" both to the outermost
internal surface and to the innermost diameter of the internal
nozzle of smaller enteral syringes. Despite the type of enteral
syringe this configuration completely eliminates unwanted fluid
buildup and inaccurate filling volumes.
[0047] In addition, molded surface features or textures may be
provided on the outer surface of each cap to provide a gripping
surface.
[0048] It should now be apparent that the above design interfaces
with and enables opening and closing the flow of medication to
enteral syringes with Luer locks and/or internal slip-nozzles while
the medication container is inverted. As such, the time to load and
unload, or upright and invert, the medication container between
syringe fillings is eliminated. In addition, the medication
container can also be shaken in an inverted position before, during
or after a syringe filling operation, when the medication so
requires.
[0049] In addition, a "smart" manufacturer-supplied medication
container is herein disclosed for bulk medicine that bears OEM
information relevant to the filling process. This way, hospital
pharmacists seeking to fill oral and enteral syringes with
medication on-demand at hospital pharmacies from bulk medication
containers supplied by OEM manufacturers have the OEM information
at their disposal when filling the syringes, saving considerable
time, effort and cost.
[0050] The OEM information relevant to the filling process is
preferably provided on the base of the bulk medicine container, by
a label or other indicia attached thereto. One skilled in the art
will understand that the label/indicia may further comprise a 2D
barcode to enable easy tracking of the medication container bearing
that cap, or may be an RFID tag or other label. Each barcode (or
possibly RFID tag or other label) preferably references the
following information:
[0051] Batch number
[0052] Expiry date
[0053] Storage instructions
[0054] Product name
[0055] Strength
[0056] Name of the active ingredient(s)
[0057] Dose form
[0058] Warning statements
[0059] NDC number (National Drug Code)
[0060] Does product need to be shaken before use? If so, how
often?
[0061] Does product need to be refrigerated before use? If so,
temp?
[0062] Does product need to be protected from light?
[0063] Volume of original bulk medication container?
[0064] The label/indicia containing the above OEM information is
most preferably attached to the bulk medication container when it
is filled by the OEM manufacturer. This way, hospital pharmacists
seeking to fill oral and enteral syringes with medication on-demand
at hospital pharmacies from bulk medication containers supplied by
OEM manufacturers have the relevant OEM information at their
disposal and can scan it or enter it into the filling system when
filling syringes. This way, the OEM data is already in the filling
system. This accomplishes the following: 1) avoids the need to log
in the medication container at the Hospital Pharmacy and input
information into the database; 2) avoids the need to replace the
standard medication cap with an adapter cap, inasmuch as the
adapted cap can be placed on the container by the OEM manufacturer
at the outset, saving labor and avoiding transcription errors by a
Pharmacy Technician; 3) saves the cost of the standard medication
cap (assuming the aforesaid adapter cap is installed by the OEM
manufacturer at the time that it is filled; 4) reduces the
possibility of the Pharmacy Technician contaminating the contents
of the bulk medication container while replacing the standard
medication cap with the adapter cap; and 5) reduces the risk of
leakage if the OEM manufacturer installs the adapter cap and then a
"leak-proof" seal overtop. None of this would not be possible if
the adapter caps are installed by the Pharmacy Technician.
[0065] Having now fully set forth the preferred embodiment and
certain modifications of the concept underlying the present
invention, various other embodiments as well as certain variations
and modifications of the embodiments herein shown and described
will obviously occur to those skilled in the art upon becoming
familiar with said underlying concept. It is to be understood,
therefore, that the invention may be practiced otherwise than as
specifically set forth in the appended claims.
* * * * *